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Clinical Trials

Infectious Disease Research

Committed to performing pharmaceutical and biotech clinical research.

General Information Clinical Trials

General Information

The Infectious Disease Research staff and Critical Care/Pulmonologists Research staff are experienced in and committed to performing pharmaceutical and biotech clinical research studies of many disease conditions, with strict adherence to institution and government regulations.

Research includes:

  • Development of medications such as antibiotics, antifungals/anti moulds, vaccines and monoclonal antibodies.
  • Treatment of sepsis/septic shock.
  • Medicated coated device/device studies.

Clinical Trials

These are among the current Infectious Disease studies currently open:

TitleA Phase 2/3 multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of golimumab induction therapy, administered subcutaneously, in subjects with moderately to severely active ulcerative colitis (T17) 28101.
PurposeThe study drug, golimumab, is a type of tumor necrosis factor (TNF) inhibitor. TNF is a naturally occurring substance in the body and may cause long-term inflammation. Golimumab may help patients with ulcerative colitis by preventing or stopping the activity of TNF and as a result reducing the symptoms of ulcerative colitis.The main purpose of this study is to determine the safety and effectiveness of golimumab, given as a subcutaneous (SC, under the skin) injection, and determine if there is a reduction of signs and symptoms (such as diarrhea, rectal bleeding, weight loss, and fever) in subjects with active ulcerative colitis.
Qualifications
  • Male or female (non-pregnant) subjects 18 years of age or older.
  • Diagnosed with ulcerative colitis on current treatment
Benefits

No additional costs for study related procedures which include:

  • Treatment provided by a gastroenterologist (specialist).
  • Study medication.
  • Lab tests, sigmoidoscopies, colonoscopies, tuberculosis screening.
  • Travel reimbursement (study visits).
ContactInfectious Disease Research nurses, 302-733-4163.

 

TitleA Phase 2, multicenter, randomized, double-blind, comparative study of the safety and efficacy of two doses of tigecycline vs imipenem/cilastatin for the treatment of subjects with hospital-acquired pneumonia (HAP) 28189.
Purpose

The main purpose of this study is to compare the safety and effectiveness of two dose levels of tigecycline with another antibiotic called imipenem/cilastatin for treating HAP (includes patients on ventilators—or breathing machine). Both antibiotics are given IV (intravenously) in the arm.

Qualifications
  • Male or female subjects 18 years of age.
  • Confirmed/suspected HAP.
  • Symptom onset occurring:
    • 48 hours after admission to the hospital, nursing home, or rehabilitation unit, or
    • Seven days after the subject was discharged from hospital (hospitalization must have been three days), or
    • 48 hours after endotracheal intubation (breathing tube placed).
  • Presence of a new or evolving infiltrate on a chest X-ray film.
Benefits

No additional costs for study-related procedures, which include:

  • Treatment provided by an infectious-disease specialist.
  • Study drug.
  • Lab tests, chest X-rays, follow-up visit (travel reimbursement).
ContactInfectious Disease Research nurses, 302-733-4163.

 

 

TitleA prospective, multicenter, investigator-blinded, randomized, comparative study to estimate the safety, tolerability and efficacy of NXL104/ceftazidime vs. Imipenem Cilastatin followed by appropriate oral therapy in the treatment of complicated urinary-tract infections (cUTI) in hospitalized adults. 28159.
PurposeThe main purpose of this study is to further evaluate the safety and effectiveness of the study drug, NXL104, given with ceftazidime (FDA approved antibiotic) in patients with a cUTI. NXL104 is being compared to Imipenem Cilastatin (FDA approved antibiotic). NXL104 is an investigational drug that is intended to stop the effect of some specific enzymes that bacteria produce that can make antibiotics less effective.
Qualifications
  • Male or female subjects 18 and 90 years of age, no pregnancy.
  • Admission to hospital.
  • Confirmed/suspected cUTI (includes pyelonephritis).

The criteria used to determine that you have a cUTI include:

  • Urinalysis indicating an infection.
  • Your overall medical condition.
  • Specific clinical signs of cUTI.
Benefits
  • No additional costs for study related procedures, which include:
    Treatment provided by an infectious-disease specialist.
  • Study medication (IV and oral).
  • Lab tests, chest X-rays, follow-up visits (travel reimbursement).
ContactInfectious Disease Research nurses, 302-733-4163.

 

TitleA prospective, randomized, double blind, double dummy, multicenter study to assess the safety and efficacy of doripenem compared with imipenem in the treatment of subjects with ventilator-associated pneumonia (VAP). 28168.
PurposeThe main purpose of this study is to compare the safety and efficacy (how well it works) of doripenem compared to imipenem (an FDA approved antibiotic often used to treat many types of infections including VAP) in patients with VAP. Both antibiotics are given by IV (intravenously).
Qualifications
  • Male or female (non-pregnant) subjects 18 years of age.
  • 48 hours on mechanical ventilation (breathing machine).
  • Presence of a new or evolving infiltrate on a chest X-ray film.
Benefits
  • No additional costs for study related procedures, which include:
    Treatment provided by a pulmonologist (lung specialist).
  • Study medication.
  • Lab tests, chest X-rays, bronchoscopy, travel reimbursement (follow-up visits).
ContactInfectious Disease Research nurses, 302-733-4163.

 

TitleA double-blind, randomized, stratified, multi-center trial evaluating conventional and high-dose oseltamivir in the treatment of immunocompromised patients with influenza. 27168.
PurposeThe main purpose of this study is to determine the safety and effectiveness of oseltamivir (Tamiflu) in immunocompromized patients suspected of being infected with the influenza (flu) virus. Immunocompromized patients include those who have had a liver or kidney transplant, or liver and kidney transplant or a stem-cell transplant. These patients are taking medications that weaken their immune system making viral infections, including influenza, much worse. Oseltamivir is FDA approved for the use in those that have a normal immune system. The use of oseltamivir in this study is investigational.
Qualifications
  • Over 18 years old.
  • Cannot be pregnant.
  • Organ (liver, kidney, or liver and kidney) transplant more than 6 months ago or a stem-cell (bone marrow) transplant that is working properly.
  • Experiencing symptoms of an influenza-like illness such as: fever, body aches, dry cough, headache, tiredness, sore throat and others.
Benefits
  • Infectious-disease-physician management.
  • Laboratory tests, immediate flu-test result.
  • Physical examination.
  • Study-related medication (oseltamivir 75mg or 150mg for 10 days).
  • May get better quicker.
  • Travel reimbursement.
ContactInfectious Disease Research nurses, 302-733-4163.

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